This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. Key Features: * Introduces a system-level approach to product design * Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification * Explains how to use theory to implement a market product (using ECG as an example) * Examines the design and applications of main medical instruments * Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. * Includes an accompanying website with the design of the certified ECG product (href="http://www.gammacardiosoft.it/book">www.gammacardiosoft.it/book) * Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.

Dr. Claudio Becchetti, RadioLabs, Italy Claudio Becchetti graduated with honors in Electronic Engineering in 1994 at the University of Rome, where he achieved the Ph.D. in Telecommunications in 1999. From 2002 to 2009, he was adjoint professor at the University "La Sapienza", faculty of Telecommunication Engineering where he held first a course on Industrial design and then a course on Signal Theory. Claudio has 7 years teaching experience working with students studying ECG. This device is well suited as a practical example for signal theory, digital signal processing, electronics and software engineering.

Professor Alessandro Neri, University of Roma TRE, Italy Alessandro Neri he received the Doctoral Degree cum laude in Electronic Engineering from the University of Rome "La Sapienza" in 1977. Since 1992 he is responsible for coordination and management of research and teaching activities in the Telecommunication fields at the University of Roma TRE, currently leading the Digital Signal Processing, Multimedia & Optical Communications at the Applied Electronics Department. His research activity has mainly been focused on information theory, signal theory, and signal and image processing and their applications to both telecommunications systems and remote sensing.

Foreword xv

Preface xvii

Acknowledgment xxi

1 System Engineering 1

Chapter Organization 1

Part I: Theory 4

1.1 Introduction 4

1.2 Problem Formulation in Product Design 4

1.3 The Business Context for Design 6

1.4 The Engineering Product Design Process 10

1.5 System-subsystem Decomposition 15

1.6 The Product Development Life Cycle 21

1.7 Project Management in Product Design 24

1.8 Intellectual Property Rights and Reuse 30

Part II: Implementation 32

1.11 The ECG: Introduction 32

1.11.1 The ECG's diagnostic relevance 32

1.11.2 ECG Types 33

1.12 The ECG Design Problem Formulation 34

1.13 The ECG Business Plan 36

1.13.1 Market Size and Trend 37

1.13.2 Core and Distinctive Features 38

1.14 The ECG Design Process 40

1.14.1 Transverse Activities of the ECG Design Process 43

1.14.2 Core Activities of the ECG Design Process 44

1.15 ECG System-subsystem Decomposition 44

1.15.1 Hardware Platform Decomposition 45

1.15.2 Software Application Decomposition 45

1.16 ECG Product Life Cycle 46

1.16.1 Overcoming Risk of Inadequate Visualization of ECG Signal 47

1.16.2 Overcoming Risk of Error Fixing in System Integration 50

1.16.3 Overcoming Risks for Non-stable/Unfeasible Requirements 50

1.17 The ECG Development Plan and Project Management 51

1.18 IPR and Reuse Strategy for the ECG 55

References 57

2 Concepts and Requirements 59

Chapter Organization 59

Part I: Theory 61

2.1 Introduction 61

2.2 The Medical Instrumentation Approach 62

2.3 Extraction of Physiological Parameters 67

2.4 Pressure and Flow 70

2.4.1 Blood Pressure 72

2.4.2 Blood Flow and Hemodynamics 74

2.5 Biopotential Recording 79

2.6 Electroencephalography 81

2.7 Electromyography 85

Part II: Implementation 88

2.8 Introduction 88

2.9 Requirements Management 89

2.10 Medical Instruments Requirements and Standards 91

2.11 ECG Requirements 94

2.12 The Patient Component 96

2.12.1 The Heart's Pumping Function and the Circulatory System 96

2.12.2 Heart Conduction 'Control' System 97

2.13 The ECG Method for Observation 99

2.13.1 Recording the Heart's Electrical Signals 99

2.13.2 ECG Definition and History 103

2.13.3 ECG Standard Method of Observation 103

2.14 Features of the Observations 108

2.14.1 ECG Signal 108

2.14.2 Clinically Significant Signal 110

2.14.3 Power Line Noise 117

2.14.4 Isoelectric Line Instability 118

2.14.5 Muscle Artifacts 119

2.15 Requirements Related to Measurements 119

2.16 Safety Requirements 126

2.16.1 EMC Performance 128

2.17 Usability and Marketing Requirements 131

2.18 Environment Issues 132

2.19 Economic Requirements 134

References 135

3 Biomedical Engineering Design 137

Chapter Organization 138

Part I: Theory 139

3.1 Design Principles and Regulations 139

3.2 General Design System Model 141

3.3 Pressure and Flow Instruments 142

3.3.1 Blood Pressure Instruments 144

3.3.2 Flow Measurements 146

3.3.3 Measuring Oxygen Concentration 147

3.4 Biopotential Instruments 148

3.4.1 Electroencephalographs 148

3.4.2 Electromyographs 151

3.5 The Design Process 152

3.5.1 The Conceptual Design 155

3.5.2 System-wide Design Decisions 156

3.5.3 System Architectural Design 157

3.5.4 Risk Management 157

Part II: Implementation 160

3.6 ECG-wide Decisions 160

3.6.1 The Gamma Cardio CG Use Case 160

3.6.2 Human Factors and the User Interface Design 161

3.6.3 Patient Interface: the Biopotential Electrodes 167

3.7 The ECG System Architectural Design 170

3.7.1 Subsystem Identification 170

3.7.2 The Communication Interfaces 171

3.7.3 Acquisition H…